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NCT00172133 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension Study of PREOS
A Phase 3 study of Osteoporosis, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,683
- Enrollment target
- 20
- Study locations
NCT00172133 is a Phase 3 study of Osteoporosis that has completed, run by Shire. The registered enrollment target is 1,683 participants, above the 1,526-participant average among 84 other Osteoporosis trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT00172133, a Phase 3 study of Osteoporosis, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,683 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.
Conditions Studied
Interventions
- DRUG ALX1-11 (drug)
Study Locations (20)
California
- 'Osteoporosis Medical Center - Beverly Hills
- 'East Bay Clinical Trial Center - Concord
- 'Loma Linda Osteoporosis Research Center - Loma Linda
- Foundation for Osteoporosis Research - Oakland
- 'Desert Medical Advances - Palm Desert
- 'VA Palo Alto Health Care System - Palo Alto
- 'Boling Clinical Trials - Rancho Cucamonga
- 'S.D. Arthritis & Osteoporosis Medical Clinic - San Diego
- 'Radiant Research - San Diego - San Diego
- 'San Francisco General Hospital - San Francisco
Florida
- 'RASF - Clinical Research Center - Boca Raton
- 'The Center for Diabetes and Endocrine Care - Hollywood
- 'Florida Wellcare Alliance - Inverness
- 'Renstar Medical Group - Ocala
- 'The Arthritis Center - Palm Harbor
Alabama
- 'The University of Alabama at Birmingham - Birmingham
- 'Rheumatology Associates of North Alabama - Huntsville
Arizona
- 'Radiant Research - Phoenix North - Phoenix
Colorado
- 'Longmont Medical Research Network - Longmont
Connecticut
- 'Northeast Clinical Research, LLC - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,683 participants |
| Start Date | 2001-10-16 |
| Est. Completion | 2005-04-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00172133
The ClinicalTrials.gov registry entry for NCT00172133 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,683 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,526-participant average among 84 other Osteoporosis trials with a reported enrollment target (10% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which ALX1-11 (drug) is the first listed.
NCT00172133 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00172133 about?
NCT00172133 is a clinical study titled "Open Label Extension Study of PREOS". This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The...
What is the current status of trial NCT00172133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,683 participants. The study started on 2001-10-16. Estimated completion is 2005-04-13.
What conditions does trial NCT00172133 study?
This clinical trial studies the following conditions: Osteoporosis.
What interventions are being tested in trial NCT00172133?
The interventions under investigation include: ALX1-11 (drug) (DRUG).
Who is sponsoring clinical trial NCT00172133?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00172133 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.